VANGUARD(TM) INSTRUMENTS 32-486259Recalls & reported problems

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304350014), received between Dec 17, 2025 and Jan 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture2

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THAT A PIN BROKE OFF IN A QUICK RELEASE CHUCK. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23975580 ↗
MalfunctionDec 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826725 ↗

Device details

UDI-DI	`00880304350014`
Brand	VANGUARD(TM) INSTRUMENTS
Model	32-486259
Company	Biomet Orthopedics, LLC
Product code	HTW · BIT, DRILL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 30, 2025

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Other BIT, DRILL devices

QUICKSET 2274-25-500
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1,985 reports
QUICKSET 2274-35-500
Depuy Orthopaedics, Inc. · BIT, DRILL
770 reports
QUICKSET 2274-30-500
Depuy Orthopaedics, Inc. · BIT, DRILL
761 reports
NA 03.037.022
Synthes GmbH · BIT, DRILL
339 reports
NA 323.062
Synthes GmbH · BIT, DRILL
309 reports
QUICKSET 2274-56-000
Depuy (Ireland) · BIT, DRILL
275 reports
QUICKSET 2274-45-500
Depuy Orthopaedics, Inc. · BIT, DRILL
211 reports
LCS 2366-83-000
Depuy (Ireland) · BIT, DRILL
207 reports

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.